The Effect of Dexamethasone 12 mg vs 6 mg on Thromboembolic Events in Patients With Critical COVID-19

NCT05195242 | Completed Phase 3 DMC

• 1 other identifier: Thromboembolism COVIDSTEROID2
• Study Type: interventional
• Target: 445
• Locations: 1 country
• Sites: 1

Brief Summary

Thromboembolisms (TEs) in patients with critical COVID-19 has been reported to be three times higher than for other critically ill patients. Immunothrombosis has been proposed as a plausible mechanism for COVID-19 coagulopathy. Corticosteroids improve survival in patients with critical COVID-19, and likely even more so with a higher dose. However, the evidence regarding the impact on the incidence of thromboembolic and bleeding events are currently uncharted. The aim of this study is to investigate if there is a difference in the incidence of thromboembolic events during ICU stay in patients with critical COVID-19 when treated with 12 mg dexamethasone compared to 6 mg dexamethasone.

Conditions

COVID-19; Thrombosis Embolism; Bleeding

Outcome Measures

Primary Outcomes (1)

• Number of patients discharged alive from the ICU without thromboembolic events

  Number of patients discharged alive from the ICU without thromboembolic events defined as pulmonary embolism, deep venous thrombosis, ischemic stroke, myocardial infarction, transient ischemic attack, other thromboembolic events

  During ICU-stay

Secondary Outcomes (3)

• The cumulative proportion of thromboembolic events

  During ICU-stay

• The cumulative proportion of bleeding events

  During ICU-stay

• The cumulative proportion of major bleeding events

  During ICU-stay

Study Arms (2)

Dexamethasone 12 mg

EXPERIMENTAL

Intravenous bolus injection of dexamethasone 12 mg once daily in addition to standard care for up to 10 days. We will allow the use of betamethasone 12 mg at sites, where dexamethasone is not available.

Drug: Dexamethasone

Dexamethasone 6 mg

ACTIVE COMPARATOR

Intravenous bolus injection of dexamethasone 6 mg once daily in addition to standard care for up to 10 days. We will allow the use of betamethasone 6 mg at sites, where dexamethasone is not available.

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

ATC code H02AB02

Also known as: Dexavit

Dexamethasone 12 mg; Dexamethasone 6 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• confirmed SARS-CoV-2 AND
• requiring at least 10l/min of O2 supplementation, non-invasive mechanical ventilation for hypoxia or invasive mechanical AND
• if previously randomised to the CS2 trial
• if they had received corticosteroids for COVID-19 during ≥5 consecutive days or use corticosteroids in doses \>6 mg dexamethasone for an indication other than COVID-19.
• active tuberculosis
• hypersensitivity to dexa-/betamethasone
• active fungal infection
• fertile woman ≤60 years of age with a positive U-HCG/P-HCG test
• informed consent not obtainable
• \- randomised in the ICU
• established thromboembolism at randomisation
• established major bleeding at randomisation

Sponsors & Collaborators

• Karolinska Institutet: lead
• Scandinavian Critical Care Trials Group: collaborator
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator
• Centre for Research in Intensive Care (CRIC): collaborator
• Aarhus University Hospital: collaborator
• Aalborg University Hospital: collaborator
• Rigshospitalet, Denmark: collaborator
• Linkoeping University: collaborator
• Stockholm South General Hospital: collaborator

Study Sites (1)

Södersjukhuset

Stockholm, Stockholm County, 11883, Sweden

Location

MeSH Terms

Conditions

COVID-19; Embolism and Thrombosis; Hemorrhage

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Rebecka Rubenson Wahlin, MD. PhD

  Karolinska Institutet Södersjukhuset

  STUDY DIRECTOR

• Maria Cronhjort, MD PhD

  Karolinska Institutet Södersjukhuset

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Consultant in Intensive Care and Anaesthesiology

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 18, 2022
• Study Start: August 27, 2020
• Primary Completion: June 20, 2021
• Study Completion: June 30, 2021
• Last Updated: June 27, 2022

Record last verified: 2022-06

Locations

SE (1)